Process Engineer

Align Technology, Inc.; Wrocław; On-site; PLN 100,000 - 145,000; Full time

Benefits offered by this job

Private healthcare Luxmed

Multisport card

Private insurance

Meal vouchers

Co-financing of company products

Employee Support Program

Job summary

Align Technology, Inc. in Wrocław is seeking a Process Engineer to improve production processes for efficiency, quality, costs, safety and ergonomics, while ensuring compliance with GMP/ISO/FDA standards.

You will implement production processes, optimize machines, perform data-driven quality analysis, and collaborate with Maintenance. You will also lead PFMEA updates, line balancing, and cost-reduction initiatives, with emphasis on project-driven process improvements.

Qualifications

• Bachelor degree in Automatics & Robotics, Mechanical or Chemical Engineering.
• At least 2 years of experience in a similar role (Medical or Automotive).

Responsibilities

• Implement and optimize production processes and machines.
• Initiate and implement process improvements.
• Solve quality and machine problems using data analysis.
• Collaborate with Maintenance on technical issues.
• Balance production lines.
• Update PFMEA, supervise process documentation.
• Lead cost-reduction activities.
• Plan and conduct validations per GMP/ISO/FDA.
• Prepare validation plans and reports.
• Perform statistical analysis of process capability.
• Report deviations and update KPI statuses.
• Assess ergonomics of equipment and workplaces.

Skills

Process optimization

Data analysis

Quality control

Cross-functional collaboration

Education

Bachelor's degree in Automatics & Robotics or Mechanical/Chemical Engineering

Job description

Process Engineer

Department: Operations

Employment Type: Fixed Term - Full Time

Location: EMEA-Poland-AFAB

Description

Improving of production processes in terms of efficiency, quality, costs, safety and workplace ergonomics. Assuring processes compliance with applicable standards and instructions. Spreading a culture of continuous improvement and development.

Role expectations

• Implementation for production and optimization of production processes and machines, engineering supervision (manual area, automates, packaging machines).
• Initiating and implementing of processes improvements
• Quality & machines problems solving based on data analysis.
• Cooperation with Maintenance Department in technical problems solving.
• Processes quality analysis and improvement – quality built in process introduction
• Production lines balancing
• Providing substantive support to production workers while new machines and technologies implementing. Instructions preparation and surveillance.
• Process documentation supervision, preparation and updating of PFMEAs.
• Cost reduction activities undertaking
• Planning and conducting of qualifications, validation and revalidation of production processes and machines in accordance with applicable GMP, ISO, FDA standards.
• Validation plans and reports preparing.
• Statistical analysis of process capability.
• Deviations and discrepancies reporting. Main KPI statuses updating and reporting.
• Ergonomics of equipment and workplaces analysis, preparation of EHS instructions.

Skills, Knowledge & Expertise

ACADEMIC BACKGROUND

Bachelor Degree or above (Automatics&Robotics; Mechanical Engineering; Chemistry Engineering preferred).

REQUIRED EXPERIENCE

Min 2 years of experience in similar position (Medical or Automotive Branch)

Job Benefits

• Private healthcare Luxmed,
• Multisport card,
• Private insurance,
• Meal vouchers,
• Co-financing of company products,
• Employee Support Program.